The new Center for Devices and Radiological Health (CDRH) Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
On January 1, 2005, the oversight responsibility was transferred to CDRH's Office of Surveillance and Biometrics (OSB) and the PAS review functions were integrated into the medical device epidemiology program. Guidance on report format and content was developed to ensure optimal PAS reporting and review. http://www.fda.gov/cdrh/osb/guidance/1561.html.
CDRH has established a new automated tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner. The effective tracking system is based on study timelines incorporated in study protocols and agreed upon by the CDRH and manufacturer.
In addition to this internal tracking system, CDRH launched this publicly available webpage to keep all stakeholders informed of their progress. It displays not only the report status, but also study status (based on protocol-driven timelines) of each PAS.
1) CONDUCT A POST APPROVAL, MULTI-CENTER, SINGLE-ARM STUDY (N-950) DESIGNED TO ADDRESS THE RELATIONSHIP OF
THE DEVICE PERFORMANCE TO PATIENT AGE, PATIENT HPV STATUS, AND COLPOSCOPIST EXPERIENCE. AT LEAST 15% OF THE SUBJECTS WILL BE 18-21 YEARS OF AGE. THE STUDY OUTCOME WILL BE THE PATHOLOGY DIAGNOSIS OF BIOPSIES TAKEN (CIN 2,3+ OR NOT) IN RELATION TO THE PHASE IN WHICH THE BIOPSIES WERE INDICATED, THE INITIAL COLPOSCOPY PHASE OR THE SUBSEQUENT (INCREMENTAL) LUMA PHASE. THIS SUTDY WILL ESTIMATE THE DETECTION RATE, THE FALSE POSITIVE RATE, AND THE MEAN INCREMENTAL INCREASE IN THE NUMBER OF BIOPSIES ASSOCIATED WITH USING THE DEVICE ADJUNCTIVELY WITH COLOPOSCOPY. THE STUDY WILL ALSO ESTIMATE THE CORRELATION BETWEEN THE PROBABIITY THAT A VIOPSY IS POSITIVE FOR CIN 2,3+ AND THE SCORE GIVEN BY THE DEVICE FOR THAT BIOPSY (THE SCORE IS A NUMERICAL VALUE CORREPSONDING TO THE COLOR DISPLAYED ON THE IMAGE RENDERED BY THE DEVICE). THE STUDY WILL EVALUATE POTENTIAL INTERACTIONS AND CONFOUNDING FACTORS THAT MAY AFFECT THE PERFORMANCE OF LUMA. RESULTS FROM THIS STUDY WILL BE USED TO UPDATE THE LABELING. 2) SUBMIT A STUDY STATUS REPORT TO FDA EVERY SIX MONTHS FROM THE DATE OF THE PMA APPROVAL ORDER AS WELL AS A FINAL STUDY REPORT WITHIN SIX MONTHS OF STUDY TERMINATION CONTAINING THE RESULTS OF ALL THE ANALYSES DESCRIBED IN THE PROTOCOL. THE POST APPROVAL STUDY REPORTS SHOULD BE SUBMITTED SEPARATELY FROM THE PMA ANNUAL REPORTS REQUIRED UNDER 21 CFR 814.84.
* Some sponsors have been under the assumption that there was a 30-60 day grace period past their due date to submit their reports to FDA. As a result they were submitting the reports to FDA after the due date. In its December 2006 post-approval studies guidance document, FDA noted that reports received after the due date were "overdue." Since then, some sponsors have contacted FDA concerned that they had been submitting reports 30-60 days past the due date because that was believed to be standard practice. To address this concern FDA has added an asterisk next to the Overdue/Received status for reports prior to April 6, 2007, to indicate that the delay was due to a temporary extension.
**Study Overdue means that the PAS study is currently overdue, the sponsor met with the FDA to discuss strategies to improve study progress, and the proposed changes are currently under FDA review.
